方伟杰 - 浙江大学

个人简介

方伟杰博士，现任浙江大学药学院研究员，博士生导师，浙江大学台州研究院医药健康中心副主任，浙江省政府特聘专家。主要从事生物药和疫苗等生物制品工艺、质量、制剂和稳定化研究，着重解决生物制品生产工艺、结构与功能复杂、不稳定性技术难题，是重磅上市生物药阿达木单抗“安健宁”制剂国内外专利的第一发明人，参与开发的多个生物药获批上市。在国际上发表第一或通讯SCI学术论文四十余篇，获得国内外专利十余项，主持多项国家、省部级和企业横向项目，包括作为两项国家重大新药创制专项课题负责人承担相应课题。获浙江省科技进步二等奖、第一届浙江省知识产权奖三等奖、中国药学会-赛诺菲青年生物制药奖。兼任浙江省药学会生物制药专业委员会副主任委员。获聘《J Pharm Anal》、《现代应用药学学报》青年编委，为十余个学术杂志担任评审专家。担任浙江省千人计划、万人计划、重点研发项目、高级工程师评审专家。作为发起人和主席连续多年举办“生物制药稳定性论坛”年度学术会议。教育经历 1999.09～2003.07 浙江大学药学院，理学学士 2003.08～2006.08 美国堪萨斯大学药学院，药物化学硕士 2006.08～2008.08 美国堪萨斯大学药学院，药物化学博士工作经历 2008.09～2011.07 美国科罗拉多大学生物制药研究中心，Research Associate 2011.08～2016.11 浙江海正药业股份有限公司，中央研究院副院长、技术总监 2016.12～2021.12 浙江大学药学院，副研究员 2021.12 至今浙江大学药学院，研究员

研究领域

· 生物制品制剂处方和工艺研究 · 生物制品分析与质量控制 · 蛋白质化学和高级结构研究

近期论文

查看导师新发文章（温馨提示：请注意重名现象，建议点开原文通过作者单位确认）

1) Du CY, Zou M, Xu ZT, Zhao W, Chen M, Fang WJ*. Tungsten residues in prefilled syringes promote monoclonal antibody aggregation and charge heterogeneity. Eur J Pharm Biopharm, 2025, in press. 2) Jin MJ, Jing ZY, Liu LD, Zheng A, Wang H, Fang WJ*. Compatibility between proteins and polysaccharide excipients in oral delivery tablets. Mol Pharm, 2025, 22(6), 2966-2975. 3) Gao H, Du CY, Zheng A, Qian C, Fang WJ*. Formulation factors affecting the formation of visible-bubbles during the reconstitution process of freeze-dried etanercept formulations: protein concentration, stabilizers, and surfactants. AAPS J, 2025, 27(1), 29. 4) Fang JT, Wang ST, Wang H, Fang WJ*. A novel peptide mapping method utilizing cysteine as a reducing agent. Pharm Res, 2025, 42(1), 173-184. 5) Liu JZ, Du CY, Gao H, Wang H, Hu F, Fang WJ*. An underlying cause and solution to the poor size exclusion chromatography performance of antibody-drug conjugates. Pharm Res, 2024, 41(12), 2299–2317. 6) Liu JZ, Li L, Fang WJ*. A novel size exclusion chromatography method for the analysis of monoclonal antibodies and antibody-drug conjugates by using sodium iodide in the mobile phase. Pharm Res, 2024, 41(9), 1893-1901. 7) Lv JY, Ingle RG, Wu H, Liu C, Fang WJ*. Histidine as a versatile excipient in the protein-based biopharmaceutical formulations. Int J Pharm, 2024, 662, 124472. 8) Gao H, Ge XZ, Liu JW, Wang ST, Xu J, Fang WJ*. Effect of annealing on visible-bubble formation and stability profiles of freeze-dried high concentration omalizumab formulations. Mol Pharm, 2024, 21, 1691-1704. 9) Jin MJ, Ge XZ, Huang Q, Liu JW, Ingle RG, Gao D, Fang WJ*. The effects of excipients on freeze-dried monoclonal antibody formulation degradation and sub-visible particle formation during shaking. Pharm Res, 2024, 41(2), 321-334. 10) Pang MJ, Wang MW, Mao LF, Guo Z, Qian C, Zheng XH, Fang WJ*. The osmolality and hemolysis of high-concentration monoclonal antibody formulations. Pharm Res, 2024, 41(2), 281-291. 11) Wang ST, Sun MF, Gao H, Shen BB, Fang WJ*. Monitoring of low-molecular-weight protein aggregation by CE-SDS as a complementary method to SE-HPLC. J Pharm Biomed Anal, 2023, 234, 115521. 12) Ingle RG, Fang WJ*. An overview of commercial nucleic acid therapeutics to address their stability and delivery challenges. Pharmaceutics, 2023, 15(4), 1158. 13) Gao H, Wang ST, Wang H, Fang WJ*. Characterization and exploration of an artifact in the reducing capillary electrophoresis-sodium dodecyl sulfate analysis of the ‘me-too’ drug zuberitamab related to rituximab. J Pharm Biomed Anal, 2023, 115347. 14) Shen BB, Yuan JJ, Qian C, Gao H, Fang WJ*. Investigation of an artifact during non-reduced capillary electrophoresis with sodium dodecyl sulfate analysis utilizing N-ethylmaleimide as an alkylation reagent. Anal Biochem, 2022, 655,114813. 15) Wang ST, Gao H, Shen BB, Wang H, Fang WJ*. Elimination of light chain tailing in reducing capillary electrophoresis with sodium dodecyl sulfate analysis of a monoclonal antibody. Electrophoresis, 2022, 43(18-19), 1850-1858. 16) Sun MF, Xu YF, Yuan JJ, Fang WJ*. Identification and characterization of chemical and physical stability of insulin formulations utilizing degraded glycerol after repeated use and storage. Eur J Pharm Biopharm, 2022, 177, 147-156. 17) Gao H, Wang ST, Hu F, Shen BB, Sun MF, Wang H, Li L, Fang WJ*. Investigation of an uncommon artifact during reducing capillary electrophoresis-sodium dodecyl sulfate analysis of a monoclonal antibody with dynamic light scattering and reversed phase high-performance liquid chromatography. Pharm Res, 2022, 39(8), 1959-1968. 18) Sun MF, Liao JN, Jing ZY, Gao H, Shen BB, Xu YF, Fang WJ*. Effects of polyol excipient stability during storage and use on the quality of biopharmaceutical formulations. J Pharm Anal, 2022, 12(5), 774-782. 19) Ingle RG, Zeng S, Jiang HD, Fang WJ*. Current development in bioanalytical sample preparation techniques for pharmaceuticals. J Pharm Anal, 2022, 12(4), 517-529. 20) Fang WJ*, Pang MJ, Liu JW, Wang X, Wang H, Sun MF. Freeze-dried biopharmaceutical formulations are surprisingly less stable than liquid formulations during dropping. Pharm Res, 2022, 39(4), 795-803. 21) Fang WJ*, Ingle RG, Liu JW, Ge XZ, Wang H. Freeze-dried monoclonal antibody formulations are unexpectedly more prone to degradation than liquid formulations under shaking stress. J Pharm Sci, 2022, 111(7), 2134-2138. 22) Jing ZY, Huo GL, Sun MF, Shen BB, Fang WJ*. Characterization of grinding-induced subvisible particles and free radicals in a freeze-dried monoclonal antibody formulation. Pharm Res, 2022, 39(2), 399-410. 23) Fang WJ*, Liu JW, Gao H, Qian YC, Gao JQ, Wang H. Secondary packages cannot protect liquid biopharmaceutical formulations from dropping-induced degradation. Pharm Res, 2021, 38(8), 1397-1404. 24) Fang WJ*, Murray TF*, Aldrich JV*. Analogs of the κ opioid receptor antagonist arodyn cyclized by ring-closing metathesis retain κ opioid receptor affinity, selectivity and κ opioid receptor antagonism. Med Chem Res, 2021, 30, 1397-1407. 25) Fang WJ*, Liu JW, Barnard J, Wang H, Qian YC, Xu J. Effects of secondary package on freeze-dried biopharmaceutical formulation stability during dropping. J Pharm Sci, 2021, 110(8), 2916-2924. 26) Fang WJ*, Liu JW, Zheng HJ, Shen BB, Wang X, Kong Y, Jing ZY, Gao JQ. Protein sub-visible particle and free radical formation of a freeze-dried monoclonal antibody formulation during dropping. J Pharm Sci, 2021, 110(4), 1625-1634. 27) Ingle RG, Fang WJ*. Prefilled dual chamber devices (DCDs)-promising high-quality and convenient drug delivery system. Int J Pharm, 2021, 597: 120314. 28) Qian C, Wang G, Wang X, Barnard J, Gao JQ, Bao W, Wang H, Li F, Ingle RG, Fang WJ*. Formation of protein sub-visible particles during powder grinding of a monoclonal antibody. Eur J Pharm Biopharm, 2020, 149: 1-11. 29) Shen BB, Zhang Z, Yuan JJ, Zheng A, Zeng S, Gao JQ, Bao W, Barnard J, Wang H, Fang WJ*. Formation of an unprecedented impurity during CE-SDS of a recombinant protein. Pharm Res, 2020, 37(11): 228. 30) Zheng HJ, Shen BB, Wang J, Wang HB, Huo GL, Huang LR, Gao JQ, Fang WJ*. Uncommon peptide bond cleavage of glucagon from a specific vendor under near neutral to basic conditions. Pharm Res, 2019, 36(8), 118. 31) Fang WJ, Murray TF, Aldrich JV*. Design, synthesis, and opioid activity of arodyn analogs cyclized by ring-closing metathesis involving Tyr(allyl). Bioorg Med Chem, 2018, 26(6), 1157-1161. 32) Wang H, Zheng HJ, Wang Z, Bai H, Carpenter, JF, Chen S*, Fang WJ*. Formation of protein sub-visible particles during vacuum degassing of etanercept solutions. Int J Biol Macromol. 2014, 66, 151-157. 33) Fang WJ, Wei Q, Kinzell J, Prestrelski S, Carpenter JF*. Effects of excipients on the chemical and physical stability of glucagon during freeze-drying and storage in dried formulations. Pharm Res. 2012, 29(12), 3278-3291. 34) Fang WJ, Yakovleva T, Aldrich JV*. A convenient approach to synthesizing peptide C-terminal N-alkyl amides. Biopolymer: Pept Sci. 2011, 96(6), 715-722. 35) Fang WJ, Bennett M, Aldrich JV*. Deletion of Ac-NMePhe1 from [NMePhe1]arodyn under acidic conditions, Part 1: effects of cleavage conditions and N-terminal functionality. Biopolymer: Pept Sci. 2011, 96(1), 97-102. 36) Fang WJ, Bennett M, Murray TF, Aldrich JV*. Deletion of Ac-NMePhe1 From [NMePhe1]arodyn under acidic conditions, Part 2: effects of substitutions on pharmacological activity. Biopolymer: Pept Sci. 2011, 96(1), 103-110. 37) Fang WJ, Cui YJ, Murray TF, Aldrich JV*. Design, synthesis, and pharmacological activities of dynorphin A analogues cyclized by ring-closing metathesis, J Med Chem. 2009, 52(18), 5619-5625.